510(k) · Cleared
ClearedIlt Torquer, Model 114TR1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intra Luminal Therapeutics, Inc. · DQX Wire, Guide, Catheter
Cleared on Jul 11, 2002 as substantially equivalent to K003398 (Boston Scientific Corporation Northwest Technology, 2000) after an 83-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Jul 11, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003398 (2000). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003398 Wireclip TorquerBoston Scientific Corporation Northwest Technology · 2000
- This deviceK021243 Ilt Torquer, Model 114TR1Intra Luminal Therapeutics, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK100093 Vsi Torque DeviceVascular Solutions, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK141054 Distal Access Torque DeviceDistal Access, LLC · 2014
- Descendant · 3 generations on · 1 of its ownK170684 Firebow Wire Torque Assist DeviceVesatek, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK221917 Stent Positioning Assistance System (SPAS)Seven Sons, Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK200120 LiteSaber Wire Torque Assist DeviceVesatek, LLC · 2020
Most influential descendants
Showing 5 of 5 · See all- K100093Vsi Torque DeviceVascular Solutions, Inc. · 2010 · cites it directly4descendants
- K141054Distal Access Torque DeviceDistal Access, LLC · 2014 · 2 generations on3descendants
- K170684Firebow Wire Torque Assist DeviceVesatek, LLC · 2017 · 3 generations on1descendant
- K221917Stent Positioning Assistance System (SPAS)Seven Sons, Ltd. · 2022 · 3 generations on0descendants
- K200120LiteSaber Wire Torque Assist DeviceVesatek, LLC · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003398 | Wireclip Torquer | Boston Scientific Corporation Northwest Technology | 2000 | — |
| 0 (this device) | K021243 | Ilt Torquer, Model 114TR1 | Intra Luminal Therapeutics, Inc. | 2002 | — |
| +1 | K100093 | Vsi Torque Device | Vascular Solutions, Inc. | 2010 | — |
| +2 | K141054 | Distal Access Torque Device | Distal Access, LLC | 2014 | — |
| +3 | K170684 | Firebow Wire Torque Assist Device | Vesatek, LLC | 2017 | — |
| +3 | K221917 | Stent Positioning Assistance System (SPAS) | Seven Sons, Ltd. | 2022 | — |
| +4 | K200120 | LiteSaber Wire Torque Assist Device | Vesatek, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003398 | Wireclip TorquerSummary page 1…er 21 CFR 870.1330) INDENTIFICATION OF PREDICATE DEVICE The ILT Torquer is substantially equivalent to the Boston Scientific Corporation wireClipTMcleared under 51O(k) K003398. DEVICE DESCRIPTION The IntraLuminal Therapeutics Torquer is a plastic device that allows for manipulating and directional contr… | 2000 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100093 | Vsi Torque Device | 2010 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The Torquer is indicated for use in manipulating a guide wire in order to access discreet regions of the vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021243 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021243: Ilt Torquer, Model 114TR1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021243
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026